Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Ondansetron + Dexamethasone; Drug: Aprepitant + Dexamethasone

• Registration Number: NCT00734929
• Lead Sponsor: Duke University

Brief Summary

We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2011-04-07
• Results First Submitted QC: 2011-05-05
• Results First Posted: 2011-06-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

A patient is eligible for inclusion in this study if all of the following criteria apply:

• Age: 18-75 years of age
• Surgery: craniotomy under general anesthesia.
• American Society of Anesthesiologists (ASA) Status: ASA: I, II, or III
• Language: Fluent in the English language
• Informed Consent: Written informed consent must be obtained.

Exclusion Criteria

A patient will not be eligible for inclusion in this study if any one or more of the following criteria apply within thirty days of patient enrollment in this clinical trial:

• Medical: Any condition that may impair a patient's ability to complete any of the study assessments or confound interpretation of results.
• Hypersensitivity: Patient has a known immediate or delayed hypersensitivity reaction or known idiosyncrasy to any of the two study medications, ondansetron, or aprepitant.
• Other Drugs: Patients should not be taking medications with known antiemetic properties (phenothiazines, butyrophenones, antihistamines), nor should they receive metoclopramide, or other antiemetics preoperatively or 12 hours before the scheduled surgical procedure.
• Pregnant or lactating females: A pregnancy test will be performed within 24 hours of entering the study for females of childbearing potential.
• Substance Abuse: Clinically significant abuse of substances (alcohol, illicit or prescribed medications) such that the patient is unable to provide informed consent or reliably complete any of the study assessments.
• Psychiatric Disease: History of a psychiatric illness that may impair the patient's ability to provide informed consent or complete any of the study assessments.
• Nausea verbal rating score (VRS): A VRS nausea score > 3 (scale 0-10) in the preoperative holding area before pretreatment with the study medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Ondansetron + Dexamethasone	Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1	Aprepitant + Dexamethasone	Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia

Primary Outcome Measures

Name	Time	Method
Cumulative Incidence of Emesis	48 h	Any vomiting or retching

Secondary Outcome Measures

Name	Time	Method
Incidence of Nausea	Post operative procedure (OP) hours (0-2, 24, 48)	operative procedure
Incidence of Vomiting (Post OP)	Post OP (0 - 2 hours)
Incidence of Vomiting (24 Hours)	24 h	Any vomiting or retching
Use of Rescue Antiemetics (Post OP)	Post OP (0 - 2 hours)
Use of Rescue Antiemetics (24 Hours)	24 h
Use of Rescue Antiemetics (48 Hours)	48 hour
Number of Participants With a Complete Response Rate	24 hours Post OP, 48 hours Post OP	complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics.
Average Nausea Score	Post OP hours 0-2, 24 h, 48 h	Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable
Number of Vomiting Episodes	48 hours
Time to First Vomiting	48 h
Number of Participants Who Rated Their Satisfaction With Antiemetic Management as "Very Satisfied"	48 hour	Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States